Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI

Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02979236

Acronym

iPOSITION

Enrollment

250

Registered

2016-12-01

Start date

2016-06-30

Completion date

Unknown

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Segment Elevation Myocardial Infarction

Brief summary

The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction

Interventions

DEVICESTENTYS Xposition S

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).

Exclusion criteria

* Cardiogenic shock * Multiple lesions requiring stenting in the target vessel. * Highly calcified lesions or excessive tortuosity at target lesion site. * Intrastent pathology. * Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines. * Female subjects of childbearing potential known to be pregnant. * Co-morbidities with life expectancy less than 1 year * Patient unable to provide written informed consent. * Known allergies to stent component.

Design outcomes

Primary

Measure	Time frame	Description
Target Lesion Failure (TLF)	12 months post procedure	target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG).

Secondary

Measure	Time frame
Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay	during the hospitalization, an average of 6 days
Target lesion failure at 30-day post-procedure	30 day post procedure
Death from any cause	12 months post procedure
Stent thrombosis rate at 30-day and 12-months after the procedure	30 days post procedure and 12 months post procedure

Countries

Italy

Contacts

Primary ContactLivio Giuliani, MD PhD

lvgiuliani@gmail.com347360091

Backup ContactSerena Rossi, MD

rossisere.rs@gmail.com3286721396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026